U.S. Pumps Billions of Dollars into HIV Care Worldwide

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The U.S. effectively subsidizes HIV medications for patients in other countries.

HIV was once widely perceived to be a death sentence—but today, more than 35 million people are living with HIV. That's as many people as have died from AIDS since the epidemic began.

Since the mortality rate peaked in 2005, it has declined by 30 percent, according to UNAIDS. Modern antiretroviral therapy (ART) is stemming the tide of heavy loss of life.

In poor countries hit hardest by HIV, access to ART drugs increased tenfold from 2002 to 2008, the World Health Organization (WHO) reports. And because the medications suppress levels of the HIV virus in the body, the risk of passing it on to others can be greatly reduced, even during unprotected sex.

But what does it cost to keep so many people alive as well as clamp down on a public health crisis across the globe? And how is greater access to ART being financed?

The United States is footing a large part of the bill. In addition to paying more than 100 times the price for some ART medications as patients in some other nations, the Kaiser Family Foundation reports that the U.S. also leads the world in providing aid to help people with HIV. President Obama asked Congress last year for $30 billion in HIV/AIDS funding for 2014, which included $7 billion in global aid. Cutbacks are expected for 2015, however.

And when it comes to keeping its own alive, the U.S. spares no expense. Third-line medications, which can cost more than $70,000 per patient per year, are provided to residents who cannot afford to pay a penny. The U.S. is one of the few countries in the world that can afford to buy third-line medications, for which there are no generics.

America's commitment to caring for its own also keeps profits high for pharmaceutical companies. “Profit margins are higher in the developed world,” Charles Flexner, a pharmacology professor at Johns Hopkins Medicine, told Healthline. “Those profits underwrite the sale of these other drugs at a reasonable cost.”

The "other drugs" are generic first-line treatments. Prices for these drugs have fallen dramatically, enabling people in poor countries to obtain them. But beyond first- and sometimes second-line treatment, lifesaving medications are still difficult to obtain worldwide.

The Price of Staying Alive

Low-income nations like those in sub-Saharan Africa pay as little as $112 per person per year for first-line HIV treatment with Efavirenz, Emtriva, and Tenofovir. A one-pill regimen costs $186 per year.

The U.S. pays $8,662 per person per year for Efavirenz alone. The costs in the U.S. for Emtriva and Tenofovir are $6,023 and $10,476, respectively, per patient per year.

The wholesale acquisition cost (WAC) is an estimate of what the drug manufacturer charges large providers. Federal law helps to set these prices.

Atripla, a preferred first-line treatment in the U.S., costs $24,019 per patient per year. It is a combination of medications similar to those used in low-income countries, but at 129 times the price.

Other first-line treatments used in the U.S., which offers a higher standard of HIV care than that set by the WHO, can cost as much as $35,000 per year.

Of the 33.4 million people around the world with HIV, 97 percent live in developing and moderate-income nations. But it is only wealthy nations like the United States that have access to preferred therapies and third-line treatments.

“Normally I wouldn’t hold the U.S. up as a great example for healthcare, but HIV is an exception,” Dr. Joel Gallant of the HIV Medicine Association told Healthline. “HIV is the one disease in the U.S. where we can say we have high quality access to care.”

AIDS Drug Assistance Programs (ADAP) is a federal program administered by each state that helps low-income people in the U.S. pay for their HIV medications. Another program, based on the Ryan White CARE Act of 1990, also provides treatment to Americans with HIV who would otherwise not be able to afford it. This year, Medicaid expansions in some states now extend healthcare beyond just the severely poor. Single people can now make up to $15,000 per year and even have some savings and still qualify for Medicaid.

But access to quality HIV medications does not come cheap for everyone in America. And with so many changes occurring in the U.S. health system, some worry about interruptions in care.

David Evans is director of research advocacy at Project Inform, a national non-profit group dedicated to improving the lives of people with HIV. He told Healthline that pharmacy benefit managers push patients toward generic drugs. But with so few generic drugs for HIV on the market, many medications end up in specialty tiers. The insured end up paying as much as half the cost. Some lower-tier insurance plans cap out at an out-of-pocket annual medication expense of $6,350 per year.

While most pharmaceutical companies offer some assistance with medication expenses, the U.S. Department of Health and Human Services has been discouraging the use of these programs. Evans said drugmaker Gilead offers assistance on up to $400 of a patient's co-pay for their most expensive HIV drug Stribild, regardless of income.

Hard-Hit Countries Provide Little Help to Citizens

UNAIDS estimates that in 2012, global HIV funding neared $19 billion. But that number remains about $5 billion short of what the agency says is required to treat people around the world.

Gallant said that countries in Western Europe, along with Canada and Australia, provide good care to their citizens with HIV. But in some sub-Saharan African countries and other nations, there is very little political will to help those suffering. “The government doesn’t make it a priority, so international donors don’t rush in to help,” he said.

He noted that the Ugandan government’s criminalization of homosexuality and recent arrest of an HIV-positive nurse. Other African nations have exhibited similar intolerance. “This could be a huge setback for public health," he said. “It shows that places doing well can go backward.”

While basic medications are accessible in most countries, many are outdated, have bad side effects, and can lose effectiveness within seven years or less. In India, where many generic medications for HIV are manufactured, only basic treatment is offered.

Middle-income countries like India and Russia have been hardest hit by the high cost of HIV medications. Only first-line medications are generally available despite growing infection rates. Russia’s HIV crisis is complicated by the country’s crackdown on homosexuality and refusal to fund needle exchange programs. A large portion of the country’s infections occur among IV drug users.

A Looming Crisis: Expensive, Patented Drugs

While the cost of HIV drugs varies around the world, a record 9.7 million people received ART medication in 2012, a 1.6 million-person boost over the previous year. But after releasing updated global treatment guidelines last year, the WHO reported that 26 million around the world actually need ART.

As medications stay on the market longer, patents expire, and competitors are able to make generic equivalents. That has happened with many of the older, first-line medications that have become available to the rest of the world. Second-line treatments are available in some nations, but at several times the price of first-line drugs.

But newer HIV medications do not have generic equivalents. A law in India allows generic drug manufacturers to also obtain patents, which could keep costs high. In a 2013 report called “Untangling the Web,” Doctors Without Borders concluded, “With upwards of 55 million people expected to need ARV therapy by the year 2030, global patent rules are contributing to a looming crisis as current drugs lose their effectiveness and their newer, patented replacements are priced out of reach for all but the wealthy.”

Stretching the Pill Supply

Dr. Flexner is working to make more pills by using less of key compounds in medications. He told Healthline that there is “a lot of excitement” around new combination ART drugs that take advantage of new and more powerful compounds recently approved or in development.

The end result is a lower daily mass dose that leaves more medication to spread around. He has written a yet-to-be-published executive summary from the 2013 Conference on Antiretroviral Drug Optimization held in Cape Town, South Africa. “The excitement revolves around the cost of goods in pharmaceutical manufacturing for products made available through generic marketplaces,” he said.

The buzz centers on dolutegarvir, which Flexner said appears to be safe and effective, and a new version of tenofovir known as tenofovir alafenamide. Producing more pills with less active ingredient could bring treatment to thousands more people. Dolutegravir may be effective at half the current dose, and the new tenofovir at less than one-tenth the dose.

With global funding for HIV medications remaining flat, research from Flexner and others offers hope to people with HIV around the world needing treatment.

For most of the world, access to third-line medications is prohibitive. "Unless you obtain them through a nation's health service or other charitable mechanism, you're not going to get these drugs," Flexner said. "Period. End of story."

Flexner noted that not all U.S. investment in keeping people with HIV alive worldwide is public. Private groups such as the Bill and Melinda Gates Foundation and The Clinton Foundation also make sizable contributions.